A Phase I Clinical Study Comparing the Pharmacokinetics, Safety, and Immunogenicity of GB221 Injection and Trastuzumab (Herceptin<sup>®</sup>) in Healthy Chinese Adults.

Zhu, Yu; Li, Chen; Chen, Liming; Liu, Haiyan; Ou, Lun; Li, Tong; Wang, Xuan; Wang, Tenghua; Tian, Jingyuan; Liang, Xintong; Hu, Zhiqin; Zhan, Yaoxuan; Xiao, Shuangshuang; Wang, Xiaole; Li, Yongmei; He, Jin; Zheng, Qingshan; Song, Haifeng; Li, Xianbo; Fang, Yi

A Phase I Clinical Study Comparing the Pharmacokinetics, Safety, and Immunogenicity of GB221 Injection and Trastuzumab (Herceptin^®) in Healthy Chinese Adults.

Zhu, Yu; Li, Chen; Chen, Liming; Liu, Haiyan; Ou, Lun; Li, Tong; Wang, Xuan; Wang, Tenghua; Tian, Jingyuan; Liang, Xintong; Hu, Zhiqin; Zhan, Yaoxuan; Xiao, Shuangshuang; Wang, Xiaole; Li, Yongmei; He, Jin; Zheng, Qingshan; Song, Haifeng; Li, Xianbo; Fang, Yi.

Affiliation

Zhu Y; Phase I Clinical Research Center, Key Laboratory of Biological Targeting Diagnosis, Therapy and Rehabilitation of Guangdong Higher Education Institutes, The Fifth Affiliated Hospital of Guangzhou Medical University, Guangzhou, 510700, China.
Li C; Phase I Clinical Research Center, Key Laboratory of Biological Targeting Diagnosis, Therapy and Rehabilitation of Guangdong Higher Education Institutes, The Fifth Affiliated Hospital of Guangzhou Medical University, Guangzhou, 510700, China.
Chen L; Clinical Trial Institution Research Ward, Peking University People's Hospital, Beijing, China.
Liu H; Phase I Clinical Research Center, Key Laboratory of Biological Targeting Diagnosis, Therapy and Rehabilitation of Guangdong Higher Education Institutes, The Fifth Affiliated Hospital of Guangzhou Medical University, Guangzhou, 510700, China.
Ou L; Beijing United-Power Pharma Tech Co., Ltd., Beijing, China.
Li T; Department of Clinical Development, Genor Biopharma Co., Ltd., Shanghai, China.
Wang X; Phase I Clinical Research Center, Key Laboratory of Biological Targeting Diagnosis, Therapy and Rehabilitation of Guangdong Higher Education Institutes, The Fifth Affiliated Hospital of Guangzhou Medical University, Guangzhou, 510700, China.
Wang T; Phase I Clinical Research Center, Key Laboratory of Biological Targeting Diagnosis, Therapy and Rehabilitation of Guangdong Higher Education Institutes, The Fifth Affiliated Hospital of Guangzhou Medical University, Guangzhou, 510700, China.
Tian J; Scientific Research Center, Guangzhou Medical University, Guangzhou, China.
Liang X; Phase I Clinical Research Center, Key Laboratory of Biological Targeting Diagnosis, Therapy and Rehabilitation of Guangdong Higher Education Institutes, The Fifth Affiliated Hospital of Guangzhou Medical University, Guangzhou, 510700, China.
Hu Z; Phase I Clinical Research Center, Key Laboratory of Biological Targeting Diagnosis, Therapy and Rehabilitation of Guangdong Higher Education Institutes, The Fifth Affiliated Hospital of Guangzhou Medical University, Guangzhou, 510700, China.
Zhan Y; Phase I Clinical Research Center, Key Laboratory of Biological Targeting Diagnosis, Therapy and Rehabilitation of Guangdong Higher Education Institutes, The Fifth Affiliated Hospital of Guangzhou Medical University, Guangzhou, 510700, China.
Xiao S; Phase I Clinical Research Center, Key Laboratory of Biological Targeting Diagnosis, Therapy and Rehabilitation of Guangdong Higher Education Institutes, The Fifth Affiliated Hospital of Guangzhou Medical University, Guangzhou, 510700, China.
Wang X; Phase I Clinical Research Center, Key Laboratory of Biological Targeting Diagnosis, Therapy and Rehabilitation of Guangdong Higher Education Institutes, The Fifth Affiliated Hospital of Guangzhou Medical University, Guangzhou, 510700, China.
Li Y; Phase I Clinical Research Center, Key Laboratory of Biological Targeting Diagnosis, Therapy and Rehabilitation of Guangdong Higher Education Institutes, The Fifth Affiliated Hospital of Guangzhou Medical University, Guangzhou, 510700, China.
He J; Phase I Clinical Research Center, Key Laboratory of Biological Targeting Diagnosis, Therapy and Rehabilitation of Guangdong Higher Education Institutes, The Fifth Affiliated Hospital of Guangzhou Medical University, Guangzhou, 510700, China.
Zheng Q; The Center for Drug Clinical Research of Shanghai University of TCM, Shanghai, China.
Song H; State Key Laboratory of Proteomics, Beijing Proteome Research Center, National Center for Protein Sciences (Beijing), Beijing Institute of Lifeomics, Beijing, China. songhf@nic.bmi.ac.cn.
Li X; Department of Pharmacology and Toxicology, Beijing Institute of Radiation Medicine, Beijing, 100039, China. songhf@nic.bmi.ac.cn.
Fang Y; Phase I Clinical Research Center, Key Laboratory of Biological Targeting Diagnosis, Therapy and Rehabilitation of Guangdong Higher Education Institutes, The Fifth Affiliated Hospital of Guangzhou Medical University, Guangzhou, 510700, China. 285641182@qq.com.

Eur J Drug Metab Pharmacokinet ; 49(3): 383-392, 2024 May.

Article de En | MEDLINE | ID: mdl-38564097

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Texte intégral: 1 Collection: 01-internacional Base de données: MEDLINE Sujet principal: Équivalence thérapeutique / Aire sous la courbe / Trastuzumab / Antinéoplasiques immunologiques Limites: Adult / Female / Humans / Male / Middle aged Langue: En Journal: Eur J Drug Metab Pharmacokinet Année: 2024 Type de document: Article Pays d'affiliation: Chine Pays de publication: France

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